Valo Therapeutics' Innovative Immuno-Oncology Therapy PeptiCRAd-1 Begins Human Trials

by Irina Bilous          Biopharma insight / News

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Topics: Novel Therapeutics   
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Valo Therapeutics Oy (ValoTx), a frontrunner in the development of advanced immunotherapies for cancer, has initiated its Phase I trial of PeptiCRAd-1, a pioneer in the realm of immuno-oncology. The first participant, enrolled in this Germany-based trial, has received the treatment without any immediate safety issues, according to the company's recent press release.

Immunotherapies for cancer refer to treatments that harness the body's immune system to combat cancer cells. These therapies work either by stimulating the immune system to work harder or smarter to attack cancer cells or by introducing components, such as man-made immune system proteins, to aid in the fight against cancer. Some types of immunotherapies include immune checkpoint inhibitors, cancer vaccines, and non-specific immunotherapies.

In recent years, several remarkable advancements have been made in the field of cancer immunotherapies. A significant one includes the advent of CAR-T cell therapy, a personalized treatment that modifies patients' T cells to fight cancer cells. A notable example is Kymriah, the first CAR-T cell therapy approved by the FDA in 2017, which is used to treat certain types of lymphoma.

Another breakthrough has been the development of PD-1 inhibitors, like Keytruda and Opdivo. These immunotherapies have shown promise in treating a variety of cancers, including lung cancer and melanoma, by blocking a pathway that prevents the immune system from attacking cancer cells.

More recently, the introduction of bispecific T cell engagers (BiTEs), such as Blincyto, have also made significant strides in treating certain types of leukemia. These drugs help to bring cancer cells and immune cells together, facilitating the immune system's ability to attack cancer cells more effectively, like with the case of Valo.


First in human clinical trial of PeptiCRAd-1 

The clinical study is set to enroll a total of 15 patients suffering from melanoma, triple-negative breast cancer, or non-small cell lung cancer. This trial will be conducted at the esteemed National Center for Tumor diseases (NCT) in Heidelberg and the Krankenhaus Nordwest in Frankfurt.

PeptiCRAd-1 leverages a tumor-specific adenovirus combined with immunogenic tumor peptides derived from NY-ESO-1 and MAGE-A3 proteins. The result is the creation of tumor-specific, cytotoxic T-cells prepared to attack and kill cancer cells.

The trial's primary objective is to ascertain the safety, immune activity, and tumor response of PeptiCRAd-1, first in isolation and then in combination with the immune checkpoint inhibitor (CPI), pembrolizumab. Furthermore, the trial aims to probe local and systemic immune activation, immune responses against NY-ESO-1 and MAGE-A3 peptides, clinical responses, and identifying biomarker-related outcomes.

This endeavor is indicative of the forward strides being made within the immuno-oncology landscape. Notably, ValoTx's CEO, Paul Higham, highlighted the potential inherent in PeptiCRAd-1 and the possibility of utilizing it in individualized or 'patient-specific' cancer treatments.


A rapidly evolving immuno oncology space

In the rapidly evolving landscape of cancer immunotherapies, several companies have emerged with unique and innovative technologies. For instance, BioNTech, a German biotechnology company, primarily known for its role in developing one of the initial COVID-19 vaccines, has also been making strides in individualized cancer immunotherapies. The company's foundational technology employs messenger RNA (mRNA) that instructs the body's cells to generate proteins capable of inciting a powerful immune response against cancer cells.

Moving across the Atlantic, the US-based Iovance Biotherapeutics is recognized for their tumor-infiltrating lymphocyte (TIL) technology. This technique centers around the extraction and amplification of TILs from a patient's own tumor. These enhanced cells are then reintroduced to the patient, orchestrating a more vigorous and targeted onslaught against the tumor.

Over in the UK, Adaptimmune is advancing therapies centered around T-cell receptors (TCRs). The company's innovative SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cells are constructed to specifically identify and eradicate cancer cells by recognizing distinct protein fragments on the cancer cell's surface. This ingenious technology enables the adjustment of TCRs to heighten their binding affinity to these cancer-related targets.

Meanwhile, Oncolytics Biotech, a Canadian company, aligns closely with Valo Therapeutics in its development of oncolytic viruses. The company's primary product, Reolysin, is a tailored formulation of the naturally occurring reovirus, designed to replicate specifically within cancer cells, causing their demise, while normal cells remain unscathed.

Lastly, another US-based biotech, Gritstone Oncology, has carved out its niche in the cancer immunotherapy space. Utilizing deep learning, the company predicts tumor-specific neoantigens—minute protein fragments exposed on the surface of cancer cells that can be identified by the immune system. This unique approach allows the design of personalized vaccines and cell therapies targeting these neoantigens, fostering a more potent and precise immune response against the tumor.

As immuno-oncology continues to establish itself as an essential weapon in the fight against various types of cancers, treatments like Valo Therapeutics’ PeptiCRAd-1 offer novel approaches to address this global health concern.

Topics: Novel Therapeutics   

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